Femtech start-up OCON Healthcare reaches recruitment goal for study evaluating treatment for heavy menstrual bleeding

OCON Healthcare, a women’s health company which develops, manufactures and commercialises an innovative 3D intrauterine drug delivery technology based on its patented IUB™ (Intra Uterine Ball) platform, has announced it had reached its recruitment goal of its Phase IIb clinical study evaluating its revolutionary IUB™ SEAD®, a non-invasive treatment for heavy menstrual bleeding.

OCON’s IUB™ SEAD is a disruptive non-invasive treatment for HMB, designed as an alternative to the traditional hormonal medication and/or aggressive and irreversible ablation procedures that are typically performed in the hospital, are non-reversible and remove the women’s chances for later pregnancy, requiring hysterectomy procedures in up to 25 per cent.

HMB is a prevalent medical condition affecting one in three women during reproductive age, causing heavy irregular bleeding from the uterus resulting in a significant decrease in their quality of life, fatigue, depression and can lead to iron deficiency, related anaemia and in acute and severe cases, can necessitate emergency medical care.

It is the fourth most common reason for an OB-GYN visit and has significant indirect costs associated with it, such as missed work or school days, decreased productivity, and increased healthcare utilisation.

Globally, the cost of HMB is estimated to be in the billions of dollars annually, highlighting the need for better solutions and management strategies for this condition.

“More women and doctors are looking today for innovative and simple solutions to treat HMB,” said Professor Sergio Haimovich, chief medical officer at OCON Healthcare.

“The IUB™ SEAD solves this medical condition with no need for irreversible ablation techniques or hysterectomies.

“This ground-breaking technology already made a positive impact on women’s lives and we are certain we will see more of it during our clinical studies in the near future.”

“The treatment with SEAD was so quick without any pain. It gave me my life back,” reported one SEAD study participant.

“I can finally leave the house without a second set of clothing after only one month.”

Keren Leshem, CEO at OCON Healthcare, added: “It breaks my heart to see so many women normalise and suffer, and even endure hospitalisation due to anaemia resulting from their heavy periods.

“It is incredibly rewarding to be part of a clinical study with one simple 30-minute procedure in the doctor’s office, that provides hope and relief to these women, and we will continue to strive towards improving their quality of life.”

The in-office procedure has been completed in over 35 women to date demonstrating safety, efficacy and significant reduction in bleeding without side effects, avoiding the need to undergo invasive uterine ablation procedures or even a hysterectomy.

Results from the company’s earlier PhIIa clinical trial showed significant reduction in bleeding of 83 per cent with 95 per cent reported quality of life satisfaction and mild pain scores (≤2 of 10).

As far as OCON is aware, the global HMB surgery market is expected to reach US$1.3bn by 2024, with 1.4 million women per year who report HMB.